Drugs@FDA: FDA-Approved Drugs
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRESAMINE | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| PRESAMINE | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| PRESAMINE | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/16/1959 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/30/1984 | SUPPL-72 | Labeling |
Label is not available on this site. |
||
| 05/01/1984 | SUPPL-71 | Labeling |
Label is not available on this site. |
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| 05/04/1983 | SUPPL-69 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/20/1981 | SUPPL-68 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/20/1980 | SUPPL-67 | Labeling |
Label is not available on this site. |
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| 04/16/1980 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/16/1980 | SUPPL-65 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/30/1980 | SUPPL-64 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/10/1979 | SUPPL-63 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/31/1980 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/01/1978 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 01/29/1980 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/29/1980 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/05/1978 | SUPPL-58 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 03/21/1978 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/21/1978 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/16/1976 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/10/1976 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/01/1975 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/01/1975 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/22/1976 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/03/1974 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |